A clinical trial to study the safety and practicability of mono polar urethral route removal of prostate without post-surgery urinary catheter traction in patients with enlarged prostate

Not yet recruiting

Conditions: Other intraoperative and postprocedural complications and disorders of genitourinary system,

Brief Summary: Thisstudy is a randomized, double blind, parallel group, clinical trial to evaluatethe safety and feasibility of Monopolar Transurethral resection of prostatewithout postoperative urinary catheter traction. The gold standardsurgical management of Benign prostatic hyperplasia is transurethral resectionof prostate. An electrified wire loop is used to remove the part ofthe prostate between the bladder neck and the verumontanum up to thedepth of the surgical capsule. Incomplete hemostasis during the operation makespost-surgical bleeding one of the major drawbacks of transurethral resection ofprostate.Traction with a urethral catheter can decrease bleeding after transurethral resection ofprostate. There is no standard protocol for the post operative management ofpatients with intraoperatively achieved hemostasis. Patients can be eithergiven traction with a urethral catheter or can avoid traction. With carefulcoagulation of venous and arterial bleeding, hemostasis can be achieved, thusavoiding the need for traction after the surgery. Also, traction results inincreased pain and analgesic consumption in patients. In this study, we will evaluate the need fortraction if hemostasis can be secured intraoperatively, which will help todecrease the morbidity associated with traction. This will be achieved bycomparing the pain score and post operative blood loss of patients with urethralcatheter traction and without urethral catheter traction.

Recruitment & Eligibility

Inclusion Criteria

prostate size of 30-80 ml.

Exclusion Criteria

1. Patients refusing to participate/give consent.
1. Patients failed to achieve Intraoperative hemostasis.
1. Patients with both BPH and bladder tumor 4) Patients with both BPH and bladder stone 5) Patients with both BPH and Urethral stricture disease 6) Patients with both BPH and meatal stenosis.

Primary Outcome Measures

Name	Time	Method
2) to compare the post operative blood loss	1) pain scores - using visual analogue score will be recorded at 6 hour,12 hour and 18 hour post surgery \| 2) Blood loss will be calculated using Bourkeâ€™s formula , preopertaive hematocrit and postoperative hematocrit will be evaluated at post operative day one.
1) To compare pain scores	1) pain scores - using visual analogue score will be recorded at 6 hour,12 hour and 18 hour post surgery \| 2) Blood loss will be calculated using Bourkeâ€™s formula , preopertaive hematocrit and postoperative hematocrit will be evaluated at post operative day one.

Secondary Outcome Measures

Name	Time	Method
1.To compare the duration of hospital stay.	2.To compare the incidence of bladder washouts and clot retention.

Locations (1): AIIMS Bhopal
🇮🇳
Bhopal, MADHYA PRADESH, India
AIIMS Bhopal
🇮🇳Bhopal, MADHYA PRADESH, India
Abhineeth K P
Principal investigator
9560252097
abhineethkp.pg2021@aiimsbhopal.edu.in