跳至主要内容
临床试验/CTRI/2024/02/063061
CTRI/2024/02/063061已完成Phase 3 4

Comparison of Early Postoperative Pain between Trans Abdominal Pre Peritoneal (TAPP) and Totally Extraperitoneal (TEP) techniques of Hernia Repair for Unilateral Inguinal Hernia : A Randomised Control Trial

Lady Hardinge Medical College1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:

试验速览

阶段
Phase 3 4
状态
已完成
入组人数
60
试验地点
1
主要终点
Mean pain at 6, 12 and 24 hours after operation using Visual Analogue scale

研究概览

简要总结

Study will be performed at the Department of Surgery at Lady Hardinge Medical College. A written informed consent from all the patients included in study and institutional review board approval will be obtained for this study.

Patients will be interviewed and the full history of their condition will be taken. Thorough clinical examination will be done. All routine investigations LFT, KFT and USG will be done for this study. Each patient will be randomly allocated to the TAPP group or the TEP group by sequentially numbered, opaque, sealed envelope technique on the day of surgery. An independent statistician, who is not involved in patient care, will generate the randomisation sequence via a computer-generated random number. The randomisation code will be contained in opaque sealed envelopes. A non-acad junior resident, who will open the envelope, will not be actively involved in outcome measurements. Before randomisations and during consent, all patients will receive an explanation of the objectives of the study, techniques and complications associated with both the procedures. The patient will be unaware of the assigned group of treatment.

In the preoperative area, a single prophylactic dose of injection ceftriaxone 1 gm will be intravenously administered after the skin test. All procedures will be performed under GA with the patients in supine and Trendelenburg position as per the conventional three ports technique. The patients will be randomised into two groups: TAPP or TEP groups. Post-operatively, an injection of paracetamol 1 gram to be infused intravenously every 8 hours on the day of surgery in all patients of both groups. The additional analgesic requirement will be fulfilled by injection diclofenac 75 mg by the intravenous route, as needed if the visual analog scale (VAS) score will be more than three. As assessment of pain to be made using the VAS score in the postoperative period at 1 hour, 6 hours, 12 hours and 18 hours.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All patients aged over 18 years with a reducible uncomplicated unilateral inguinal hernia undergoing elective laparoscopic hernia repair.

排除标准

  • conversion to open, conversion from TEP to TAPP.

结局指标

主要结局

Mean pain at 6, 12 and 24 hours after operation using Visual Analogue scale

时间窗: Mean pain at 6, 12 and 24 hours after operation using Visual Analogue scale

次要结局

  • Mean diclofenac consumption during first 24 hours after surgery(1 to 4)
  • Mean operative time in each technique(30 to 300 minutes)
  • Mean time in days to return to work(1 to 10 days)
  • Proportion of patients having complication within one week of operation - bowel, bladder, vascular injury, serum formation, surgical site infection(yes or no)

研究者

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

Katyayni Singh

Department of Surgery, Lady Hardinge Medical College and associated hospitals

研究点 (1)

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