Vaginal reconstruction during laparoscopic radical hysterectomy for cervical cancer patients

JRCT ID: jRCT1030210227

Registered date:06/08/2021

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: PS 0-1
• Date of first enrollment: 01/08/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): During laparoscopic uterine malignancies surgery for cervical cancer patients, after vaginal cutting and sample collection, the bladder surface peritoneum and rectal surface peritoneum are sutured to the vaginal stumps of the anterior and posterior walls, respectively. Then, the bladder surface peritoneum and rectal peritoneum surface are sutured with an absorbent thread at the target vaginal length (about 7-10 cm) to form the blind end of the new vagina. A prosthesis is placed in the vagina at the end of surgery to prevent vaginal stenosis. After the operation, the prosthesis will be instructed to be put on and taken off, and it will be put on and taken off about once a day. While checking for vaginal epithelialization and stenosis, the prosthesis is placed for about 3-6 months after surgery, and sexual intercourse is permitted after confirming vaginal stump fusion and vaginal epithelialization. After the operation, in addition to the usual cancer screening, a vaginal examination is also performed.

Outcome(s)

• Primary Outcome: Anatomical vaginal length immediately after surgery

Secondary Outcome

Vaginal shortening rate and anatomical vaginal length 1 year after surgery
Presence / absence / frequency of sexual life
Presence or absence of sexual dysfunction 1 year after surgery
Incidence of adverse events during surgery
Incidence of adverse events during follow-up 1 year after surgery
Tumor recurrence rate
Presence or absence of postoperative adjuvant therapy

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Female

Include criteria

1. Patients who strongly desire to maintain sexual function after surgery
2. Histopathological diagnosis of cervical cancer has been obtained.
3. FIGO classification (FIGO2008), advanced stage IA, IB1, IIA1 stage
4. Tumor diameter is 2 cm or less in preoperative evaluation
5. No marked cervical stromal infiltration of the tumor was observed in the preoperative evaluation
6. Preoperative diagnostic imaging shows no lymph node metastasis or distant metastasis
7. ECOG PS 0-1 at the time of consent acquisition
8. The age at the time of obtaining consent is 20 years old or older and 70 years old or younger.
9. The consent of the person has been obtained for participation in this research.

Exclude criteria

1. The principal investigator or the investigator has determined that participation in this research is inappropriate.
2. Informed consent can't be obtained.
3. It is judged that there is an extremely high possibility of performing postoperative adjuvant therapy after surgery.
4. Have a mental illness that affects will confirmation

Related Information

• Primary Sponsor: Kisu Iori