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Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Hybrid Transvaginal-Transabdominal Endoscopic Surgery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01039129
Enrollment
0
Registered
2009-12-24
Start date
2009-12-31
Completion date
2012-10-31
Last updated
2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Appendicitis, Gallstones, Pelvic Pain

Keywords

Gallstones, Appendicitis, Pelvic pain, Peritoneal mass

Brief summary

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.

Interventions

PROCEDUREEndoscopic Cholecystectomy

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.

PROCEDUREEndoscopic Appendectomy

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

PROCEDUREEndoscopic Peritoneoscopy

A diagnostic peritoneoscopy with or without biopsy for any indication

Sponsors

St. Luke's-Roosevelt Hospital Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Technical successintra-operative
Complication1 month

Secondary

MeasureTime frame
Operative timeintra-operative
Sexual function1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026