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| ID | Type | Description | Link |
|---|---|---|---|
| 29/11/2019 Protocol N10 | Registry Identifier | Azerbaijan Medical University |
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The goal of this clinical trial was to compare two surgical techniques in female patients with full-thickness rectal prolapse. The main questions it aimed to answer were:
Researchers compared modified rectosacrouteropexy with pelvic peritonization with conventional Wells rectopexy to assess postoperative recurrence, complications, anorectal manometry, defecography findings, and pelvic floor symptom scores. Participants underwent one of the assigned surgical procedures and were followed after surgery with clinical assessment and pelvic floor function testing.
This is a prospective randomized comparative study conducted at Azerbaijan Medical University. Female patients with full-thickness rectal prolapse are assigned to modified rectosacrouteropexy with pelvic peritonization or conventional Wells rectopexy. Participants are followed for postoperative anatomical and functional outcomes, including recurrence, complications, anorectal manometry findings, defecography findings, and pelvic floor symptom scores.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm Title: Modified rectosacrouteropexy | Experimental | Participants undergo modified rectosacrouteropexy with pelvic peritonization for full-thickness rectal prolapse. |
|
| Arm Title: Wells rectopexy | Active Comparator | Participants undergo conventional Wells rectopexy for full-thickness rectal prolapse |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified rectosacrouteropexy | Procedure | Surgical treatment for full-thickness rectal prolapse using modified rectosacrouteropexy with pelvic peritonization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative rectal prolapse recurrence | Recurrence of full-thickness rectal prolapse after surgery, assessed during postoperative follow-up | Up to 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative complications | Occurrence of postoperative complications, including constipation, fistula formation, and mesh-related complications. | Up to 24 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Female patients with full-thickness rectal prolapse were eligible for this study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Surgery, Biochemistry | Baku | AZ1030 | Azerbaijan |
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| ID | Term |
|---|---|
| D012005 | Rectal Prolapse |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Wells rectopexy | Procedure | Conventional surgical rectopexy procedure for full-thickness rectal prolapse |
|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |