Study on the outcome of DJ-Stent v/s Stentless laparoscopic ureterolithotomy: A randomized controlled trial

STUDY ON THE OUTCOME OF DJ-STENT V/S STENTLESSLAPAROSCOPIC URETEROLITHOTOMY: A RANDOMIZED CONTROLLED TRIAL

PROTOCOL OF THESIS FOR THE DEGREE OF DIPLOMATE OFNATIONAL BOARD

(GENERAL SURGERY)

 SUBMITTED TO

NATIONAL BOARD OF EXAMINATIONS, NEW DELHI

 SUBMITTED BY

DR. AKRITI

DNB (TRAINEE)

DEPARTMENT OF GENERAL AND MINIMALLY INVASIVE SURGERY

NAZARETH HOSPITAL

SHILLONG, LAITUMUKHRAH

793003

PHONE: 0364-2224052 / 2210188

  UNDER THE GUIDANCE OF

GUIDE                                                                                                 CO-GUIDE

Text Box: DR. JAYANTA KUMAR DAS (MS, FMAS)SENIOR CONSULTANTGENERAL SURGERY & MISNAZARETH HOSPITALText Box: DR. GORDON M RANGAD (MS)C.M.O &HEAD OF THE DEPARTMENT GENERAL SURGERY & MISNAZARETH HOSPITAL

 SYNOPSIS

•      Thepurpose of this study is to evaluate the need of ureteral stenting afterLaparoscopic Ureterolithotomy. This randomized controlled study will comparethe outcome of placing ureteral stent in one group while no stent placement inanother group.

•      Demographic details & investigationreports will be collected pre-operatively followed by laparoscopicureterolithotomy with or without DJ stent placement as per randomisation.

•      Intra and Post-operative data collectionwill be done according to pre-defined parameters, followed by comparison andstatistical analysis of the outcomes in the respective groups to arrive at aconclusion.

                    INTRODUCTION

Urolithiasis and its management have become a globalgrowing concern posing both clinical and economic burden for healthcaresystems. With the steady rise of populations, the annual prevalence of urinarytract stones is increasing and as well as the requirement for hospital visits.Ureter stone has a lifetime prevalence of 10% to 15% and is one of the mostcommon urological presentations. (1)

 Patients experience severe flank pain radiating togroin because of sudden obstruction of the ureter, with associated risks ofhydronephrosis, renal damage, infection of the urinary tract and severe sepsis.Ureteric stones can be managed by different modalities; expectant managementwith spontaneous passage of the stone, with or without medical expulsivetherapy as an adjuvant. Those that fail to pass stones spontaneously willrequire more invasive options.(1)

 Shock wave lithotripsy (SWL) and ureteroscopy (URS)are the most commonly preferred methods for the treatment of ureteral stones.However, their use for large upper and middle ureteral stones remainscontroversial. Particularly with impacted stones, the success rate of SWL andURS diminishes, and when the stone size exceeds 1 cm, SWL efficacy decreasesfrom 84 to 42%. (2)

 Although 7% of the ureteral stones treated withendourological methods require repeated treatment, 1% –10% of such patients mayneed open surgery. Open surgery has the advantage of a high success rate in onesession for such complicated patients. Because open surgery increases thelength of hospital stay and requires additional analgesic treatment for thepatient, laparoscopic ureterolithotomy (LU) has recently become an alternativemanagement method. It has been proposed that the success rate of LU is similarto that of open surgery but it is superior to open surgery in reduced analgesicrequirement, hospital stay, recovery, and cosmetic outcome.(2)

 The first use of a double-J stent (DJ stent) wasreported by Zimskind et al. in 1967. Since then, after any open or endoscopicurological procedure, short duration placement of ureteric DJ stent has becomealmost routine. Of course, over the last few years, there is controversy onwhether a DJ stent should routinely be kept after laparoscopic ureterolithotomy(LU). (3)

    Despite the rapid development of surgical techniques,there are still some debates about whether it is necessary to place a urinarystent to drain, and which type of stent is better. However, which is superioramong DJ stented and stent-less procedures remains unclear. Even though manystudies have compared the differences between these procedures, no clearconclusions have been drawn. Nowadays, Whether or not to place stents and whichtype of stents to place in clinical practices mainly depends on the surgeons’preference and experience. (4)

 Complications of DJ stent:

·       Urinarytract infections

·       Stentmigration

·       Stentfracture

·       Stentencrustation

·       Forgottenstent

·       Needfor a second procedure

                   NEED FOR THE STUDY

 Eventhough previous studies have compared the differences between stented andstentless laparoscopic ureterolithotomy, no clear conclusions have been drawn.More studies in this discipline are needed owing to the lack of consensus toindicate the use of ureteral stents post ureterolithotomy.

    REVIEW OF LITERATURE

Key words used :

Ureterolithotomy(595 results)

Stentless (461results)

DJ Stentureterolithotomy ( 6 results)

Stentlessureterolithotomy India ( 1 result)

  Filters used:

Up to 10 years

Meta-analysis

  Â·       Five of the few studies done on adults similar to mytitle have been tabulated and one Indian study done on pediatric population hasbeen separately mentioned in the text following.

Currentlypublished literature related to these studies have been tabulated below:

STUDY

PLACE

STUDY DESIGN

SAMPLE SIZE

CONCLUSION

|i) Ahmed  hammady et al.

(JOURNAL OF ENDOUROLOGY)

(5)

(Egypt)

2011

RCT

(52/52)

LU without stent placement for large upper ureteral stones is safe, cost effective, has less operative time, and needs no auxiliary procedures when compared with the use of stent after LU, which adds costs and discomfort for the patient.

|ii) Cavalli Ac et al.

(JOURNAL OF BRAZILIAN COLLEGE OF SURGEONS)

(6)

(Brazil)

2011

RETRO-SPECTIVE STUDY

(15 stentless/16 stented)

The number of early and late complications was lower in patients operated with the use of double-J catheter.

In relation to operative time, analgesic and length of hospitalization, both groups were similar.

|iii) Hossein Karami et al.

(JOURNAL OF ENDOUROLOGY)

(7)

(Iran)

2012

RETRO-SPECTIVE

(23/23)

Placing a Double J catheter during the surgery does not increase the time of operation and may play a role in prevention of urinary extravasation after LUL.

|iv) Jae Hyung You et al.

(KOREAN JOURNAL OF UROLOGY)

(8)

(South Korea)

2014

RETRO-SPECTIVE STUDY

(17 stented/

24 stentless)

Laparoscopic ureteral stone surgery without D-J stenting is safe, economical, and less inconvenient for patients.

|v) Mohammad Hossein et al.

(JOURNAL OF LAPARO-ENDOSCOPIC & ADVANCED SURGICAL TECHNIQUES)

(9)

2017

SYSTEMATIC REVIEW AND META-ANALYSIS

(142 stented/

147 stentless)

The rate of prolonged urine leakage, time to drain removal, and estimated blood loss were not significantly different between the two groups.

STUDY 1)

Results: Allprocedures were performed successfully. The mean operative time was 48 minutesin group 1 vs 65 minutes in group 2. The mean drainage time was 4.1 days ingroup 1 vs 2.3 days in group 2. All the patients were followed up for a periodof 6 months with no recorded cases of residual stone or ureteral stricture.

STRENGTH: Theoperation was performed by the same surgeon

WEAKNESS:

·       Themethodology of randomization not mentioned.

·       The longer operative time was attributed topositioning of the patient before stent insertion i.e. stenting time not consideredseparate entity

STUDY 2)

Results: The groups weresimilar as for age and gender, degree of dilation of the urinary tract,position and average size of the calculi (Group 1 = 15.5 ± 6.6 mm, Group 2 =16.3 ± 6.1 mm). Operative time was also not significantly different (Group 1 =130 ± 40.3 min, Group 2 = 136.3 ± 49.3 min). Group 1 had six patients (37.5%)with early (four cases of urinary fistula) and late complications (one case ofstenosis of the ureter, one case of functional exclusion of the operatedkidney), while Group 2 had no complications, This difference was statisticallysignificant (p = 0.011).

STRENGTH:

·        Pre-operative andpost-operative serum creatinine and IVU was done

·       Analgesic use defined post-operative day wise

WEAKNESS:

Greater amounts ofanalgesics used than the series in the literature.

The authors thusconsider the effective control of pain, the reason for shorter hospitalizationtime.

STUDY 3)

Results: In one case, thestone was pushed back. The stone-free rate was 97.8%. There were four cases ofprolonged urinary leakage after the surgery. All of them were in the group inwhose members the Double J catheter had not been placed. The problem wasresolved in one patient spontaneously after 4 days, but for the other threepatients, a Double J catheter was placed and the leakage was stopped in 24hours. There was no case of urinary leakage in the second group of patientswith a placed Double J catheter.

 STRENGTH: Singlesurgeon performed all the surgeries.

WEAKNESS: Study design unclear as first 23 patientsunderwent stentless surgery and next 23 receive stent successively (due to fewcomplications observed in stentless group)

STUDY 4)

Results: The mean patientage, serum creatinine levels, and stone size were not significantly differentbetween the two groups. The stone-free rate was 100%. The mean operative timewas significantly shorter in the stentless group than in the stent group (59.48minutes vs. 77.88 minutes, p＜0.001).Parenteral analgesic use and anticholinergic medication use were observed inthe stent group only. The blood loss, drain removal day, and hospital stay werenot significantly different between the two groups. No other significantcomplications occurred during or after the operation in any patients.

STRENGTH: Singlesurgeon performed all surgeries.

WEAKNESS: Lackof an imaging study such as ultrasonography or CT scans to confirm ureteralstrictures in all the subjects

  STUDY 5)

Results: Four studies with289 participants were included in the study. There was no significantdifference between two groups in rate of prolonged urine leakage (odds ratios[OR] 0.35, 95% confidence intervals [CI] 0.09–1.46, p = 0.15). Significantlonger operative time was detected in patients who underwent stented LUcompared with stentless group (mean difference 11.36, 95% CI 7.53–15.20, P <.00001). There was no significant difference between two groups in day of drainremoval (mean difference -1.09, 95% CI -2.33–0.15, P = .08). No significantdifference in blood loss in patients who underwent stented LU compared withstentless group was detected (mean difference 7.67, 95% CI -0.29–15.64, P =.06).

STRENGTH: Systematic review of already existingstudies

WEAKNESS: A study on paediatric population wasincluded along with 3 studies on adults for meta-analysis which might givefalse results.

  STUDY 6)

 Indian study:

Conductedat Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow, Uttar Pradesh226010, India

LaparoscopicUreterolithotomy in Children: With and Without Stent — Initial Tertiary Care Experiencewith More Than 1-Year Follow Up (10)

Method: Impactedureteric stone of size 1.5 cm or ureteric stones that were refractory to shockwave lithotripsy (SWL)/ureteroscopy (URS) were considered for LU. From December2009 to April 2012, 50 cases of LU were performed with a stent being placed.From May 2012 onward we now perform stentless LU and till now we have doneapproximately 64 such type of cases. Out of these, 48 have completed more than1 year of follow-up and we took these as our study group and the previous 50(LU with stent) as our control group. Baseline characteristics along withcertain per- and postoperative findings of the two groups were noted andanalyzed. Ultrasonography and X-ray kidney, ureter, and bladder region weredone at 3, 9months, 1 year, and yearly thereafter. Intravenous urography wasdone at 6 months statistical analysis was performed by using SPSS ver. 21 (SPSSInc., Chicago, Illinois, United States). The data were analyzed by using theMann–Whitney test and a p value of < 0.05 was considered significant.

 **Results:**The baselinecharacteristics were similar in both the groups with 100% stone clearance inall. LU with stent differed from the stentless group in terms of morerequirement of analgesics and the need for a second procedure for stentremoval, but with no cases of urine leak in the postoperative period.

   LACUNAE IN LITERATURE:

•      Noneof the studies have considered stenting time as a separate entity whileestablishing operative time for the stented group. Stenting time will vary withdifferent stenting methods.

•      Notenough number of randomized controlled trials have been done.

•      Most of the studies have been done outsideIndia. Also there are no studies in the north eastern part of the country whereurolithiasis is largely prevalent.

 RESEARCH QUESTION

IS LAPAROSCOPIC URETEROLITHOTOMY WITHOUT DJ STENTNON-INFERIOR TO DJ STENTED URETEROLITHOTOMY?

AIMS AND OBJECTIVES

To evaluate the outcomes of performing laparoscopicureterolithotomy with and without DJ stent placement in patients of uretericcalculus/calculi in terms of:

·      operativetime

·      natureand quantity of drain output

·      durationof drain removal

·      hospitalstay in days

·      post-operativecomplications

      MATERIALS AND METHODS

Approvalof INSTITUTIONAL SCIENTIFIC COMMITTEE AND ETHICAL COMMITTEE has been taken as apre-requisite. The study will be registered in the CLINICAL TRIALS REGISTRY OFINDIA. While conducting the study, informed written consent will be taken afterexplaining the need and importance of the study prior to filling of thepatient’s proforma to rule out future conflicts. A detailed clinical historyalong with general and systemic examination and various relevant investigationswill be done.

Studysetting:

The study will be conducted in Nazareth Hospital, Shillong, Meghalaya - a tertiary care hospital

Studypopulation:

Patients of ≥ 18 years of age who will be presentingwith ureteric calculus/calculi undergoing laparoscopic ureterolithotomy andfulfilling inclusion criteria.

Study design:

The study will be a RANDOMIZED CONTROLLED TRIAL.

Inclusioncriteria:

1)Patients who consent

2)Patients ≥ 18 years of age

3)Patients withureteric calculus/calculi of size ≥ 1 cm

 Exclusioncriteria:

1. Pregnant patients
2. Stone associated with radiologically diagnosed ipsilateral stricture ureter.

 Follow upperiod:

All patients to befollowed up to a period of 3 months post-surgery.

  Duration ofstudy:

The duration ofthe sample collection will be from 1st December 2020 to 30th November 2021 and all patients will befollowed up till 3 months.

Sample sizecalculation:

The followingstudy has been used to calculate sample size:

 (8) YouJH, Kim YG, Kim MK et al.

   n= { 2 [Φ¯¹ (α) + Φ¯¹ (β)] ² σ²}

(μ1-μ2)²

Φ¯¹ =Cumulative distribution function for standardized normal variant.

μ1 & μ2 = Mean outcomes in the 2 groups

where μ standsfor mean duration of drain removal in the two groups , details of which arealready mentioned in the review of literature.

P value will be calculatedto establish the significance of  theparameter mentioned.

σ= Standard deviation

α= 5%

Power= 80%

SAMPLE SIZE  =   38   in each arm (including 10 % dropouts)

OPERATIONALDEFINITION

 **SIZE OF STONE:**The size of the stone will be defined in the greatest diameter measured. Forthis study stone size greater than or equal to 1cm will be considered.

Methodology:

Patient selection:

·      Patients â‰¥  18 years diagnosed with uretericcalculus/calculi of size ≥ 1 cm will undergo randomization into 2 groups

·      Informedconsent will be taken from all the patients undergoing surgery along withconsent for stent placement before randomization.

·      BLOCKRANDOMISATION will be done in a combination of block of 6 & 4.

·       The randomization will be done on the previous eveningof the day of surgery.

·      Preformed opaque envelopes will be prepared with group name either A or Bmentioned on the inside.

·      Envelopserial number, block identifier and block sequence will be mentioned on the outsidein the sequence of block randomization.

·      Envelopswill be dispensed successively to the selected patients serially.

·      Theenvelop will be opened by the patient himself/herself.

·      Groupname will be recorded in the proforma sheet as per the result.

 Surgery : Allpatients will undergo laparoscopic ureterolithotomy under general anesthesia.

Stent: Double- Jstent made up of polyurethane will be used in all patients to be stented.

Surgeons: Thesurgeons performing surgery have experience greater than 100 cases.

  Group with DJ Stent(GROUP A) : Patient in this group will have DJ stent insertion postlaparoscopic ureterolithotomy on the corresponding side.

Group without DJstent (GROUP B): Patient in this group will not have DJ stent insertion postlaparoscopic ureterolithotomy.

 *Serumcreatinine will be repeated on post-op DAY 3 for both the groups

  Followingparameters to be compared for both the groups:

1.     Operative time

-Stenting time separately (in stented group)

2.     Nature & Quantity of drain output

3.    Durationof Drain removal

4.    Durationof hospital stay

5.    Post-operativecomplications (up to 3 months)

  Method offollow up: All patients areto be followed up as per advised at the time of discharge till a period of 3months.

STATISTICAL ANALYSIS**:**

1. Data collected will be entered and analyzed using IBM SPSS 22(IBM corporation, Armonk, NY, USA)
2. Qualitative variables will be expressed as percentages.
3. Quantitative variable will be expressed as MEAN +/- STANDARD DEVIATION (for normally distributed data) or MEDIAN + IQR for non normally distributed data.
4. For qualitative variables χ² test of independence association & FISCHER’S test will be used
5. For quantitative data variable MANWHITNEY-U TEST, T-test & ANOVA test wherever applicable
6. P<0.05 will be considered significant

ETHICAL CONSIDERATION

 THESTUDY WILL BE UNDERTAKEN AFTER OBTAINING PERMISSION FROM INSTITUTIONAL ETHICAL COMMITTEEAND STANDARD GUIDELINES WILL BE FOLLOWED. INFORMED CONSENT WILL BE TAKEN FROMTHE PATIENTS BEFORE RECRUITING THEM FOR STUDIES AFTER EXPLAINING RISK ANDBENEFITS IN A LANGUAGE PATIENT WILL COMPLETELY COMPREHEND.

BIBLIOGRAPHY

1.    Yallappa S, Amer T, Jones P, Greco F,Tailly T, Somani BK, et al. Natural History of Conservatively Managed UreteralStones: Analysis of 6600 Patients. J Endourol. 2018;32(5):371–9.

2.     RajendranP, Senthil K. Laparoscopic ureterolithotomy. Oper Atlas Laparosc Reconstr Urol.2009;20(1):291–300.

3.     DasJ, Rangad G. A new and easy technique of double-J stenting afterretroperitoneal laparoscopic ureterolithotomy: A discussion of othertechniques. Urol Ann. 2020;12(4):309.

4.      LiuX, Huang C, Guo Y, Yue Y, Hong J. Comparison of DJ stented, external stentedand stent-less procedures for pediatric pyeloplasty: A network meta-analysis[Internet]. Vol. 68, International Journal of Surgery. Elsevier Ltd; 2019[cited 2020 Oct 14]. p. 126–33. Available from:https://linkinghub.elsevier.com/retrieve/pii/S1743919119301530

5.      HammadyA, Gamal WM, Zaki M, Hussein M, Abuzeid A. Evaluation of ureteral stentplacement after retroperitoneal laparoscopic ureterolithotomy for upperureteral stone: Randomized controlled study. J Endourol. 2011;25(5):825–30.

6.      CavalliAC, Tambara Filho R, Slongo LE, Cavalli RC, Rocha LC de A. The use of double-Jcatheter decreases complications of retroperitoneoscopic ureterolithotomy. RevCol Bras Cir [Internet]. 2012;39(2):112–8. Available from:http://www.ncbi.nlm.nih.gov/pubmed/22664517

7.      KaramiH, Javanmard B, Hasanzadeh-Hadah A, Mazloomfard MM, Lotfi B, Mohamadi R, et al.Is it necessary to place a Double J catheter after laparoscopicureterolithotomy? A four-year experience. J Endourol. 2012;26(9):1183–6.

8.      YouJH, Kim YG, Kim MK. Should we place Ureteral stents in retroperitonealLaparoscopic Ureterolithotomy?: Consideration of surgical techniques andcomplications. Korean J Urol. 2014;55(8):511–4.

9.      SoltaniMH, Shemshaki H. Stented Versus Stentless Laparoscopic Ureterolithotomy: ASystematic Review and Meta-Analysis. J Laparoendosc Adv Surg Tech.2017;27(12):1269–74.

10.    Srivastava A, Dhayal IR, Rai P.Laparoscopic Ureterolithotomy in Children: With and Without Stent - InitialTertiary Care Center Experience with More Than 1-Year Follow-Up. Eur J PediatrSurg. 2017;27(2):150–4.

 ANNEXURES

I.        CASESHEET (STUDY PROFORMA)

1. Name:
2. Age:
3. Sex:
4. MRN:
5. Address with contact number: _______________________________________________________________________________________________________________________________________________________________________________________________________________
6. PRE-OP INVESTIGATION (APPLICABLE):

DIAGNOSTIC INVESTIGATION

 SIZE OF URETERIC CALCULUS

LOCATION OF URETERIC CALCULUS

|XRAY (KUB)

    |USG

    |IVU

    |CT SCAN

  7.    X-rayKUB Report (POST-OP)

 DJ STENT INSITU:                YES                                                       NO

                 8.    Operativetime:

Stenting time(stented):

    

9.    Total quantity of drain output:

Text Box: Day:

 | | | --- | | |

    10.  Duration of Drain removal:

  11.  Hospital stay in days:

  12.  Timeperiod from date of surgery till removal of stent:

  13.  Complications post operatively:

Within(time span):

              PATIENT INFORMATION SHEET

 I, Dr. AKRITI aspart of my D.N.B thesis, am conducting a study comparing the outcome oflaparoscopic ureterolithotomy with and without stent placement.

The purpose of thestudy is to find out whether putting a stent is superior to stentless surgery.

As part of thisstudy you will be either receiving or not receiving DJ stent while undergoingsurgery.

The selection willbe random and data will be collected according to predefined parameters forcomparison.

It will be helpful if you can take part inthis study to see whether DJ stent insertion helps with quicker recovery ,lesser hospital stay and lesser/no post-operative complications.

The superiority ofeither of the methods has not yet been well established to call one better overthe other.

As part of the study, you are requested tofollow up with us till 3 months as advised after discharge.

By taking part in the study you are helpingthe society for a greater cause .

The data collected from you will be keptconfidential and will not be revealed to anybody and will not be used for anyother purpose except for my research work.

If you need moreinformation regarding the stent or anything related to my study you can contactme or my guide DR. JAYANTA KUMAR DAS and my co-guide DR. GORDON M RANGAD .

           PATIENT INFORMATION SHEET

NGA I DR. AKRITI, KUM KA BYNTA JONG KA JINGPULE JONGNGA,NGA LEH KAWEI KA JINGPULE BNIAH KABA PYNIANUJOR IA KA JINGMYNTOI HAPDENG JONGKA LAPAROSCOPIC URETEROLITHOTOMY DA KABA BUH IA U STENT BAD DA KA BA KHLEM BUHIA U STENT.

KA JINGTHMU JONG KANE KA JINGPULE KA LONG BA YN BUH IAU DJ STENT LANE YN NYM BUH HA KA POR BA SUMAR/PUID IAPHI.

KANE KAN IARAP LADA PHI LAH BAN SHIM BINTA HA KANE KAJINGPULE BAN PEIT BNIAH BA DA KA BA BUH IA UNE U DJ STENT, U LAH NE EM BANIARAP BAN KHLAIN KLOI NA KA JINGSHITOM, NE BAN SAH KHYNDIAT SNGI HA HOSPITALBAD BAN PYNDUNA IA KI JINGMA BAD JINGSHITOM HADIEN.

KUM KA BYNTA KA JINGPULE, NGA KYRPAD IA PHI BAN WANPYNI DOKTOR HADUH 3 BNAI KUMBA LAH BATAI HA KA POR BA IOH MIH NA HOSPITAL.

PHI LAH IARAP IA KA IMLANG SAHLANG SHIBUN DA KA BASHIM BYNTA HA KANE KA JINGPULE BNIAH JONGNGA.

KIEI KIEI KI BA PHI IATHUH IANGI KIN LONG BEIT TANGHAPHI BAD NGIN NYM IATHUH NE PYNBNA HANO HANO.

BAD RUH KANE KADEI TANG KA JINGPULE BNIAH HI, YM DEINA KA BYNTA KINO KINO KIWEI PAT KI JINGTHMU.

LADA PHI KWAH TIP BNIAH SHUH SHUH SHAPHANG KANE KAJINGPULE JONGNGA , PHI LAH BAN PHONE IA NGA LANE KYLLI IA KI NONGHIKAI JONGNGA, KITA KIDEI I

DR. JAYANTA DASBAD I DR. RANGAD.

Text Box: DR GORDON M RANGADMS,CMOHOD DEPARTMENT OF GENERAL SURGERY & MISNAZARETH HOSPITAL,SHILLONG

           INFORMED CONSENT FORM

Subjectidentification number for this trial:

 Title of theproject: - STUDY ON THE OUTCOME OF DJ-STENT V/S STENTLESS LAPAROSCOPICURETEROLITHOTOMY: A RANDOMIZED CONTROLLED TRIAL

 Name of theprincipal investigator: DR. AKRITI , Mob no. 9340952563

I have receivedthe information sheet on the above study and have read and/or understood thewritten information. I have been given the chance to discuss the study and askquestions.

I consent to takepart in the study and I am aware that my participation is voluntary. Iunderstand that I may withdraw at any time without this affecting my futurecare.

I understand thatthe information collected about me from my participation in this research andsections of any of my medical notes may be looked at by responsible persons(ethics committee members / regulatory authorities).

I give access tothese individuals to have access to my records.

I understand I will receive a copy of thepatient information sheet and the informed consent form.

 Signature/thumbimpression of subject                                                                         Date

 Printed name ofthe subject in capitals

 Signature/thumbimpression of the legally accepted representative                               Date

KAJIGPYNTIP BAN AI JINGMYNJUR

Serial no.-

KA PHANG JONG KA JING PULE**: STUDY ON THE OUTCOME OF DJ-STENT V/S STENTLESSLAPAROSCOPIC URETEROLITHOTOMY: A RANDOMIZED CONTROLLED TRIAL**

KA KYRTENG JONG KA NONGWAD JINGTIP BA KONGSAN:  DR. AKRITI , 9340952563

 NGA LA IOH IAKA LAD BANIAPHYLLIEW JINGMUT BAD BANTIPKHAM BNIAH HALOR KANE KA PHANG PDENG.

NGA AI IAKA JING MANJUR BAN SHIM BYNTA HAKANEKAJINGWAD BNIAH,NGA SNGEWTHUH BAD NGA SHIM BYNTA DA KA MON BA LAITLIUD BAD NGALAH BAN KYLLI JINGKYLLI.

NGA SNGEWTHUH BA NGA LAH BAN KYNRAN DIEN HA KANO KANOKA POR KHLIEM KA JINGKTAH IAKA JINGAI JINGSUMAR KABA HADIEN HABUD.

NGA SNGEWTHUH BA KA JINGTIP BALA LUM SHAPHANG JONG NGAHA KANE KA JINGWAD BNIAH BA IA DEI BAD KA JINGAI JINGSUMAR LAH BAN KHMIH DA KIBRIEW KI BA IA DONBYNTA HAKANE KA JINGWAD BNIAH NGA AI LAD IAKINE KI BRIEW BANKHMIH IAKA JINGTOH BA IA DEI BAD KA JINGAI JINGSUMR IANGA.

NGA SNGEW THUH, BA NGAN SA IOH PDIANG IAKA JINGTHOH BADON IAKA JINGTIP U/KA NONGPANG BAD IAKA JINGTHOH JINGPYNTIP BAN AI JINGMYNJUR.

                                                                                                                                                                        JINGSOI----------------------------------------                            JINGSOI--------------------                                                                                         KYRTENG--------------------------------------                            KYRTENG-------------------------

(NONGPANG)                                                                       (NONGSAKHI)

                                                                                                                                                                                                                              KYRTENG DOKTOR                                                            JINGSOIBAD KA SEAL

                                                    TARIK----------------

KAPOR------------------