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OpenTrials
Completed

NCT Number: NCT05421117

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

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 After the mass has been placed in it, the bag is withdrawn, closed, and expelled through the skin incision with simultaneous trocar removal.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

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Key information

Age range

16 year–80 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-Patients with missing data about surgery information

Treatment and study plan

Laparoscopic adnexal mass extraction

Procedure

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.

Primary outcomes

  1. Incisional pain score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Erzincan Military Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 16, 2022
Registry last updated
Jun 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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