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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LVMR | Experimental | Modified Laparoscopic Ventral Mesh Rectopexy |
|
| LVMR with STARR | Experimental | Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Laparoscopic Ventral Mesh Rectopexy | Procedure | This group will undergo modified laparoscopic ventral mesh rectopexy alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Monitoring of complications started in the hospital and is followed up in the outpatient setting until 12 months after surgery. | 0 to 12 months after surgery |
| Changes in the Patient Assessment of Constipation- Quality of Life score (PAC-QoL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Fu, MD | Contact | 86-13720120190 | futao1975@tom.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Gastrointestinal Surgery II, Renmin Hospital of Wuhan University | Recruiting | Wuhan | Hubei | 430060 | China |
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| Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection | Procedure | This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection |
|
This is a measure of efficacy. |
| 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. | Baseline, 1, 3, 6, and 12 months after surgery |
| Changes in Cleveland Clinic Fecal Incontinence Score (CCFI) | This is a measure of efficacy. | Baseline, 1, 3, 6, and 12 months after surgery |
| Changes in Fecal Incontinence Quality of Life Scale (FIQoL) | This is a measure of efficacy. | Baseline, 1, 3, 6, and 12 months after surgery |
| Radiological outcome as assessed by defecography | This is a measure of efficacy. | Baseline and 12 months after surgery |
| Changes in the ODS score (ODS-S) | This is a measure of efficacy. | Baseline, 1, 3, 6, and 12 months after surgery |
| ID | Term |
|---|---|
| D012005 | Rectal Prolapse |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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