Comparison of Laparoscopic Adnexal Mass Extraction Via the Transumbilical and Transvaginal Routes

Completed

• Conditions: Surgical Procedure, Unspecified
• Interventions: Procedure: Laparoscopic adnexal mass extraction

• Registration Number: NCT05421117
• Lead Sponsor: Erzincan Military Hospital

Brief Summary

Adnexal masses are a common clinical problem encountered in gynecological practice. Minimally invasive surgery (MIS) for ovarian pathologies has been adopted widely. Its goals are to minimize abdominal incisions and postoperative pain and to prevent incisional complications, such as incisional hernias and adhesions. Compared with open procedures, MIS is associated with faster recovery times, better patient quality of life, and lower postoperative complication rates. The removal of an adnexal mass from the abdominal cavity is performed most commonly using the suprapubic, umbilical, or vaginal route. Apart from these, mini laparoscopy can provide a better cosmetic result without additional operative time or complications. Despite the limited use of mini laparoscopy for gynecological procedures, its use has increased recently.

After excision, an adnexal mass can be removed through a laparoscopic (LS) port using a variety of endoscopic or containment bags. After the mass has been placed in it, the bag is withdrawn, closed, and expelled through the skin incision with simultaneous trocar removal. When a mass is large or cannot be removed through the port, the incision may be enlarged slightly. This situation may yield a cosmetically worse outcome and increases the risk of postoperative complications, such as adhesion, hernia, and increased postoperative pain. Thus, natural orifice surgery (NOS) has emerged for tissue removal in such cases.

This study was performed to compare the transumbilical (TU) and transvaginal (TV) routes for adnexal mass removal from the abdominal cavity

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2022-06
• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-12
• Last Update Submitted: 2022-06-12
• Study First Posted: 2022-06-16
• Last Update Posted: 2022-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

Inclusion Criteria

-Women who underwent laparoscopic surgery for the removal of benign adnexal masses

Exclusion Criteria

-Patients with missing data about surgery information

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
transumbilical (TU) routes	Laparoscopic adnexal mass extraction	For the TU group, a surgical glove was created bag during the operation as follows: a sterile, surgical latex glove (size 8.5) was double tied at the level of the wrist, the fingers were removed, and a 75-cm purse-string suture was made using a symmetrical knot to form a bag. The glove bag took an average of 10 min to make. It was lubricated with normal saline to remove the talcum powder and then introduced through the 10-mm umbilical port (optic port). The fingers of the glove were removed to facilitate its insertion with the 10-mm trocar and for ease of movement in the abdominal cavity.

Primary Outcome Measures

Name	Time	Method
Incisional pain score	The time between the end of the surgery and 3 hours after the operation	Each patient was asked by the care nurse or assistant doctor to record the severity of incisional pain on a Visual Analogue Scale (0, no pain; 10, unbearable pain) 3 hours after surgery.