Safety of gut clamper in laparoscopic modified radical hysterectomy for cervical cancer

JRCT ID: jRCTs072190044

Registered date:06/02/2020

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cervical cancer
• Date of first enrollment: 02/03/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Use of Gut clamper in laparoscopic modified radical hysterectomy

Outcome(s)

• Primary Outcome: Safety
• Secondary Outcome: Postoperative vaginal stump infection

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Female

Include criteria

1. Cervical cancer, clinical stage IA1-IA2, or IB2 with a tumor diameter of 2 cm or less.
2. Indications for laparoscopic modified radical hysterectomy.
3. It is over 20 years old at the time of signing informed consent.
4.The diagnosis should be histologically from the cervical primary lesion as follows. 1) Squamous cell carcinoma 2)adenosquamous cell carcinoma 3) Adenocarcinoma
5.Pelvic lymph node metastasis or distant metastasis is not detected on CT or PET-CT.

Exclude criteria

1) Double cancer
2) Infection requiring systemic treatment.
3) Fever over 38 on the day of surgery.
4) Women with pregnancy or breastfeeding
5) Patients with psychosis or psychiatric symptoms who are difficult to participate in the study
6) Continuous systemic administration of steroids.
7) Continuous insulin administration or poor controlled diabetes
8) Poor controlled hypertension.
9) Patients judged to be inappropriate for safe laparoscopic hysterectomy by physician.

Related Information

• Primary Sponsor: Mekaru Keiko
• Secondary ID(s): Nil known