Hybrid Transvaginal-Transabdominal Endoscopic Surgery

St. Luke's-Roosevelt Hospital Center

Status: Withdrawn

Conditions: Appendicitis; Gallstones; Pelvic Pain

Treatments: Procedure: Endoscopic Cholecystectomy; Procedure: Endoscopic Appendectomy; Procedure: Endoscopic Peritoneoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01039129

SLR IRB#09-136

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Endoscopic Cholecystectomy

Experimental group

Description:

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).

Treatment:

Procedure: Endoscopic Cholecystectomy

Endoscopic Appendectomy

Experimental group

Description:

Participants will with chronic appendicitis will undergo appendectomy through this experimental approach.

Treatment:

Procedure: Endoscopic Appendectomy

Endoscopic Peritoneoscopy

Experimental group

Description:

20 patients in this arm will undergo diagnostic peritoneoscopy with or without biopsy for any indication.

Treatment:

Procedure: Endoscopic Peritoneoscopy