跳至主要内容
临床试验/CTRI/2025/08/092783
CTRI/2025/08/092783尚未招募不适用

Evaluation of the usefulness of Martius fat pad flap in rectovaginal fistula and complete perineal tear repair- A case control study

Richa Vatsa1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Percentage of patients having complete symptomatic relief after surgery as calculated by Cleveland Clinic Incontinence scores

研究概览

简要总结

Both rectovaginal fistula (RVF) and complete perineal tear (RVF) results in abnormal communication between the vagina and rectum. Both these conditions lead to significant discomfort to patients and lead to impairment of quality of life. All these lead to significant psychological distress for patients. The success rate of RVF repair is 69%-80%, as reported in the literature. The failure of repair occurs due to compromised vascularity, infection, and repair under tension.  Martius fat pad flap (MFPF) uses vascularised fatty tissue from the labia to provide vascularity to the repaired tissue.  These flaps have been used for the repair of both VVF and RVFs. The success rate reported in the literature with these flaps is 65-100%.

Groups: Two groups will be there, depending on surgeon’s discretion of choice of surgery.

Cases: Patients who will undergo RVF or CPT repair with the use of MFPF

Control: Patients who will undergo RVF or CPT repair without the use of MFPF

Methodology:

The patients of RVF and CPT who who will undergo repair will be recruited. Details like age, demographic profile, cause of RVF/CPT, previous repair, surgical details, postoperative recovery, and any complication during surgery placement will be noted. Incontinence will be measured using Cleveland Clinic Incontinence scorespre- and post surgery. Then surgical details will include the type of surgery, duration of surgery and blood loss. The outcomes will be compared between two groups, one with MFPF and one without MFPF. The patients of the prospective part of the study will be called for regular follow-up for pain on Days 0, 3, 7,30 and 90 for prospective cases on a VAS score of 10. Further, sexually active patients will be asked to fill out a female sexual function index (FSFI) questionnaire pre- and at least 6 months post-surgery.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Patients with surgery for RVF or CPT repair with the use of MFPF Control
  • Patients with RVF or CPT repair without the use of MFPF.

排除标准

  • RVF and CPT repair with colostomy Controls
  • RVF and CPT repair with colostomy.

结局指标

主要结局

Percentage of patients having complete symptomatic relief after surgery as calculated by Cleveland Clinic Incontinence scores

时间窗: Percentage of patients having complete symptomatic relief after surgery as calculated by Cleveland Clinic Incontinence scores at Day 0, 1 month, 3 month and 6 month post surgery

次要结局

  • 1. Surgical site infection in the postoperative period(2. Wound breakdown in the postoperative period)

研究者

发起方
Richa Vatsa
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Richa Vatsa

All India Institute of Medical Sciences, New Delhi

研究点 (1)

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