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临床试验/NCT07087756
NCT07087756招募中不适用

The Effect of Temporary Ovarian Suspension to the Anterior Abdominal Wall During Laparoscopic Endometriosis Surgery for Adhesion Prevention -A Comparative and Prospective Study

Carmel Medical Center1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年3月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
76
试验地点
1
主要终点
Adhesion formation following laparoscopic surgery with temporary ovarian suspension as assessed in post-operative ultrasound visits at weeks 6,13 following surgery

研究概览

简要总结

Pelvic adhesions, particularly between ovaries and pelvic sidewall, frequently complicate endometriosis surgery. Despite various interventions, no widely accepted solution exists. Small studies suggest temporary ovarian suspension may reduce adhesion formation. This technique, which temporarily elevates ovaries postoperatively, shows promise but requires further investigation to confirm its efficacy and long-term outcomes.

This prospective, single-blinded, randomized controlled study compares adhesion formation in endometriosis patients at risk for ovarian adhesions. Participants are randomized to undergo laparoscopic surgery with temporary ovarian suspension or standard care without ovarian suspension. Pain and suture removal eagerness are assessed via daily questionnaires. Blinded ultrasound experts evaluate adhesions at 6 and 13 weeks postoperatively. No anti-adhesive barriers are used to minimize confounding factors

详细描述

Endometriosis is a chronic condition characterized by growth of endometrial tissue in sites other than the uterine cavity, most commonly in the pelvic cavity, including the ovaries, the uterosacral ligaments, and the pouch of Douglas. Laparoscopic excision of endometriosis lesions has become the gold standard treatment. At follow-up, relief of pain and quality of life after endometriosis surgical treatment ranges between 50% and 95%. However, pelvic surgery for endometriosis has been associated with a high rate of postoperative adhesion formation. The incidence of pelvic adhesions at second-look laparoscopy in the initial few weeks after surgery has been reported to be between 50% and 100%. The ovaries are the most common site involved by adhesions because of their anatomic localization (close to the pelvic sidewall and the homolateral tube) and the fragility of the coelomic epithelium that covers the ovarian surface [7,8]. In addition, when the posterior pelvic compartment is involved, obliteration of the pouch of Douglas is often observed as a result of a post-inflammatory process causing ovarian adhesions [9]. Women with higher risk for postoperative ovarian adhesions include those who have preoperative ovarian adhesions or patients undergoing ovarian cystectomy, peritonectomy of the ovarian fossa or extensive pelvic adhesiolysis. Postoperative retained free fluid with blood and postoperative infections may also increase the risk for adhesions. Postoperative adhesions are a source of major concern because of their potential consequences including persistent pelvic pain, dyspareunia (difficult or painful sexual intercourse), infertility, intestinal obstruction, and complications at subsequent surgery.

A wide range of interventions has been tried in the past in order to reduce postoperative pelvic adhesions. This includes intra-peritoneal administration of anti-adhesive solutions such as icodextrin and hyaluronic acid. Various drugs including steroids and heparin have also been tried in the past but none of them have gained wide acceptance (Metwally et al., 2006; Kamel, 2010). Oxidized regenerated cellulose was found to reduce postoperative adhesion in two very small RCTs (Ahmad et al., 2008).

Intra-operative suspension of the ovaries to the anterior abdominal wall is sometimes used to facilitate ovarian retraction and improve exposure of the pelvis during surgery for severe endometriosis (Cutner et al., 2004). Temporary ovarian suspension can be achieved using a straight needle and absorbable suture to suspend the ovary to the abdominal wall with an external knot tie that can be easily removed at any time after surgery. Two small observational studies suggested that temporary ovarian suspension for 4-7 days following surgery for severe endometriosis may reduce the frequency of postoperative pelvic adhesions (Abuzeid et al., 2002; Ouahba et al., 2004).

The Objective of the Study The primary objective of the study is to examine adhesion formation following laparoscopic surgery with temporary ovarian suspension removed a week after surgery.

The secondary objective is the analyze patient symptoms and adherence to the ovarian suspension as well as request to remove the suture before one week post operative.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Patients with moderate to severe endometriosis with suspected adhesions, lesions in the ovary, ovarian fossa, utero-sacral ligaments, pouch of douglas, or involvement of the intestine as seen in preoperative assessment who are willing to participate in the study including postoperative follow-up assessments.

排除标准

  • •Patients who are not intended to have an endometriosis operation. Patients with minimal to mild endometriosis and no suspected adhesions or ovarian, ovarian fossa, utero-sacral ligament, pouch of douglas involvement on preoperative assessment.

研究组 & 干预措施

Suspended Ovary

Active Comparator

Ovary suspended during laparoscopy for endometriosis surgery

干预措施: laparoscopic ovarian suspension (Procedure)

Non-suspended ovary

Sham Comparator

Ovaries not suspended during laparoscopy for endometriosis

干预措施: laparoscopic ovarian suspension (Procedure)

结局指标

主要结局

Adhesion formation following laparoscopic surgery with temporary ovarian suspension as assessed in post-operative ultrasound visits at weeks 6,13 following surgery

时间窗: From enrollment to last follow-up visit at 13 weeks post surgery

The primary objective of the study is to examine adhesion formation following laparoscopic surgery with temporary ovarian suspension removed a week after surgery. Assessment of adhesions will be performed by ultrasound before surgery and then at 6 week and 13-week post-surgery. Assessment will be performed by an ultrasound specialist who is blinded to the surgical procedure. Adhesions are marked as negative or positive per organ including left and right ovary, left and right tube and other locations (rectosigmoid, uterus, bladder, pouch of Douglas).

次要结局

  • Patient pain during the first week following laparoscopy(From enrollment to 1 week post-operative follow-up visit)
  • Patient tolerability to ovarian suspension during the first week following surgery(From enrollment to 1 week post-operative follow-up visit)

研究者

发起方
Carmel Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuval Kaufman

Head of the Multidisciplinary Center for the Treatment of Endometriosis

Carmel Medical Center

研究点 (1)

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