A comparative analysis between the closure of appendicular stump with one endoloop and two endoloops in Laparoscopic Appendicectomy.

A comparative study betweensingle vs double endo-loop to appendicular stumps in LaparoscopicAppendicectomy

The cases for the surgery willbe taken from Department of General surgery.

About 100 patientsare expected to participate in the study. By using the ChiSquare formula, and taking the Level of Significance as 0.05 and Power as 0.80with Degrees of Freedom 1 , the sample size of of each case and control of thesudy is 50 This sample size was acquired with the Chi-square formula. Patient are divided into studygroup(single loop) and control group(double loop). The study group will be thefirst 50 patients who belong to the inclusion criteria and the next 50 patientsfill in the control group. The cases for the study will be taken from theDepartment of General Surgery. The diagnosed patients who are filling in theinclusion criteria of the study are taken up in the sample. A data collectionproforma will be filled up by the prinicipal investigator. Immediatepost-operative complications will be monitored Routine clinical evaluation is done by theprincipal investigator and reports shall be assessed as a part of the study.Noadditional tests will be done during follow up. Study will go on for a durationof 2 years. Patient diagnosed with Appendicitis and falling in the inclusioncriteria will be randomized into study group and control. Post operatively theywill assesses based on cost of treatment, operative treatment, time of stay andpost-operative complications and statistically analysed at the end of the study.Inclusion Criteria: Age more than18years.Clinical diagnosis of appendicitis.Cases completed by laparoscopicapproach. All cases of Laparoscopic Appendectomy with normal Appendix.   Exclusion Criteria: Age less than 18yearsold. Patient on anticoagulant therapy. Patient with known bleeding disorders. Casesof abdominal TB and Inflammatory bowel diseases. All patients with uncomplicated appendicitis areconsidered for the study. Once the patient is evaluated planned and consentedfor laparoscopic appendicectomy, patient will be provisionally included in thestudy and taken consent for the same. Patient demographics and other detailswill be interviewed and filled as per the proforma. The treating physician willexplain the use of endoloop for the procedure. Intra-operatively, if thepatient falls in the inclusion criteria, he/she will be recruited in the studydefinitely and will be followed up for a period of one month. There is no addedrisk to the participant as being a part of the study apart from thoseassociated with the standard Laparoscopic Appendectomy procedure. The patient may not get any benefit from participating inthis study.  If the patient takes part inthis study it may help other patients  tohave only to be able to put only one endoloop at the appendicular stump area. Thealternative treatment is the application of two endoloops at the appendicularstump area. No Additional costs for participating in the study. Alltests done are part of standard of care and only reports are collected by theresearcher. Information from the study recordsincluding your name, address, medical records, results of tests, study resultswill be kept confidential and will be reviewed only by authorized personnel fromthe sponsor or their representative, Ethics Committee or regulatorybodies.  The data will not be madeavailable to another individual unless you specifically give permission inwriting. Information and results from this study may be presented at meetingsor published in journals without including your name and personalidentifications. No reference will be made in oral or written reports whichcould link you to the study