跳至主要内容
临床试验/CTRI/2025/11/098026
CTRI/2025/11/098026尚未招募4 期

COMPARISON OF ABSORBABLE TACKERS VERSUS UNIDIRECTIONAL BARBED ABSORBABLE SUTURES FOR CLOSING PERITONEAL FLAP IN TRANS ABDOMINAL PRE-PERITONEAL HERNIA REPAIRS: A RANDOMISED CONTROLLED TRIAL

Armed Forces Medical College1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
20
试验地点
1
主要终点
To compare post operative pain following TAPP (VAS score) at 1, 3 , 7 , 30 days and 6 months.

研究概览

简要总结

A hernia is the abnormal protrusion of an organ or tissue through a defect in the surrounding wall, most commonly seen in the inguinal region. Inguinal herniorrhaphy is one of the most frequently performed operations by general surgeons. With the rise of minimally invasive surgery, laparoscopic hernia repair has become widely practiced and is considered the preferred approach for bilateral and recurrent inguinal hernias. The two main laparoscopic techniques are transabdominal preperitoneal repair described in 1992 and totally extraperitoneal repair described in 1993. The TAPP procedure is easier to learn but requires entry into the peritoneal cavity, making mesh fixation and peritoneal closure a technical challenge.

Various methods exist for peritoneal closure in TAPP including tackers, staples, fibrin glue, and sutures. The choice depends on surgeon skill, institutional practices, postoperative pain outcomes, and cost. Tackers may increase cost and cause persistent groin pain, fibrin glue is painless but expensive, and sutures are cost effective but require advanced laparoscopic skills and increase operative time. The introduction of 3D 4K imaging has improved laparoscopic suturing, reducing operating time and enhancing depth perception.

TAPP repair performed by experienced surgeons is safe with recurrence rates similar to open surgery. Complication rates range between 2.5 and 27 percent, with common issues including postoperative pain, seroma, and recurrence, and rare cases of bowel obstruction. Peritoneal closure remains a key step since tackers can cause adhesions and suture knots may fail leading to herniation.

This study aims to compare two peritoneal closure techniques in TAPP repair focusing on postoperative pain, operative duration, and long term complications.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients between 18-65 yrs undergoing unilateral or bilateral Laparoscopic TAPP hernia repair.
  • Written informed consent.

排除标准

  • Patients with history of recurrence.
  • Patients with comorbidities- smokers, bronchial asthma, on steroid or immunosuppressive therapies.
  • Patients unfit for general anaesthesia or ASA more than III e.
  • Patients unwilling for regular follow up.

结局指标

主要结局

To compare post operative pain following TAPP (VAS score) at 1, 3 , 7 , 30 days and 6 months.

时间窗: 1, 3 , 7 , 30 days and 6 months.

次要结局

  • • Operative time(• Seroma formation)

研究者

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR SAYANDEEP SAHA

ARMED FORCES MEDICAL COLLEGE

研究点 (1)

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