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

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05421117
• Other study ID #: MUGLA-7
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2022
• Source: Erzincan Military Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 After the mass has been placed in it, the bag is withdrawn, closed, and expelled through the skin incision with simultaneous trocar removal.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 80 Years

Eligibility

Inclusion Criteria:

-Women who underwent laparoscopic surgery for the removal of benign adnexal masses Exclusion Criteria: -Patients with missing data about surgery information

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Procedure:
• Laparoscopic adnexal mass extraction
Compared with open procedures, Minimally invasive surgery (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, trans umbilical (TU), or trans vaginal (TV) route.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan Military Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional pain score	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.	The time between the end of the surgery and 3 hours after the operation