Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Study Overview
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Brief Summary
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The is a pilot study to evaluate the safety and efficacy of hybrid transvaginal-transabdominal procedures. Diagnostic peritoneoscopy (visualizing the inside of the abdomen), appendectomy (removal of the appendix), and cholecystectomy (removal of the gallbladder) will be performed through a vaginal incision with an additional small incision in the umbilicus.

Official Title
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Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Conditions
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Gallstones, Appendicitis, Pelvic Pain

Intervention / Treatment
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* Procedure: Endoscopic Cholecystectomy
* Procedure: Endoscopic Appendectomy
* Procedure: Endoscopic Peritoneoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic or early appendicitis Symptomatic gallstones Suspicious abdominal mass/nodule Female Age 18-60 years ASA Class I or II Exclusion Criteria: Pregnant women History of previous abdominal, pelvic, or vaginal surgery History of previous abdominal or pelvic radiation therapy History of fibroid uterus History of endometriosis History of large ovarian cyst History of unexplained vaginal bleeding or dyspareunia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic Cholecystectomy<br>20 patients in this arm will undergo cholecystectomy, or removal of the gallbladder, through this experimental approach. This arm will compose of patients with symptomatic gallstones (cholelithiasis). | Procedure: Endoscopic Cholecystectomy<br>* An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus.<br>|
| Experimental: Endoscopic Appendectomy<br>Participants will with chronic appendicitis will undergo appendectomy through this experimental approach. | Procedure: Endoscopic Appendectomy<br>* An incision will be made in the vagina and a flexible surgical camera (endoscope) and instruments will be introduced. The surgical procedure for each given arm will be performed with the aid of an additional surgical instrument inserted through a small incision in the umbilicus<br>|
| Experimental: Endoscopic Peritoneoscopy<br>20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication. | Procedure: Endoscopic Peritoneoscopy<br>* A diagnostic peritoneoscopy with or without biopsy for any indication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  | intra-operative | 
| Complication |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative time |  | intra-operative | 
| Sexual function |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gallstones, Appendicitis, Pelvic pain, Peritoneal mass