An interventional study of Modified Laparoscopic Ventral Mesh Rectopexy and Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection in Obstructive Defecation Syndrome, Chronic Constipation and Rectal Prolapse, sponsored by Renmin Hospital of Wuhan University. Recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-15.
Sponsored by Renmin Hospital of Wuhan University · Not applicable, Interventional, and Treatment
Obstructed defecation syndrome (ODS) is a common problem in women. Rectal prolapse and rectocoele are frequently identified in patients with ODS. Surgery is the only definite treatment for those patients and is preferably performed minimally invasive. The most used procedures are laparoscopic ventral mesh rectopexy (LVMR) and stapled trans-anal rectal resection (STARR). However, high-level prospective studies on treatment strategies for ODS currently are lacking and, thus, no consensus exist regarding the optimal treatment for patients with ODS. This study aimed to compare LVMR alone and LVMR combined with STARR evaluating functional and anatomical results.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's planned enrollment of 126 is above the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →Renmin Hospital of Wuhan University is the lead sponsor of 86 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Modified Laparoscopic Ventral Mesh Rectopexy
Procedure: Modified Laparoscopic Ventral Mesh Rectopexy
Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
Procedure: Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection
This group will undergo modified laparoscopic ventral mesh rectopexy alone
This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection
Changes in the ODS score (ODS-S)
The primary outcome measure will be the change in total ODS score (ODS-S) measured at 12 months after surgery.
Time frame: Baseline and 12 months after surgery
Postoperative complications
Monitoring of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery.
Time frame: 0 to 12 months after surgery
Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL)
This is a measure of efficacy.
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Changes in Health-Related Quality of Life
SF-36 version 1 will be used to measure changes in the health-related quality of life. This is a measure of efficacy.
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Changes in Cleveland Clinic Fecal Incontinence Score (CCFI)
This is a measure of efficacy.
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Changes in Fecal Incontinence Quality of Life Scale (FIQoL)
This is a measure of efficacy.
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Radiological outcome as assessed by defecography
This is a measure of efficacy.
Time frame: Baseline and 12 months after surgery
Changes in the ODS score (ODS-S)
This is a measure of efficacy.
Time frame: Baseline, 1, 3, 6, and 12 months after surgery
Plan to share: No
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Renmin Hospital of Wuhan University