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Resection of the sigmoid-rectum is a procedure frequently required in cytoreductive surgery for advanced ovarian cancer, and it is also among the procedures with the highest risk of complications. One of the major, albeit uncommon, complications of intestinal anastomosis is anastomotic leakage. According to the literature, the rate of anastomotic leakage following cytoreductive surgery for ovarian cancer ranges from 1.7% to 17%.
The risk factors associated with this complication are varied and often inconsistent across studies. They range from preoperative clinical conditions-such as age, low albumin levels, and Body Mass Index < 18-to intraoperative factors such as low to mid rectal resection, high ligation of the inferior mesenteric artery, and multiple bowel resections.
Apart from the rehabilitative programs introduced by the Enhanced Recovery After Surgery protocol-which aim to improve the nutritional status of patients undergoing cytoreductive surgery for ovarian cancer-we currently lack validated tools to reduce the risk of leakage. The most commonly used strategy remains the creation of a protective stoma. However, several studies have shown that this procedure is not actually a protective factor against anastomotic leakage; rather, its utility lies in mitigating the severity of the complication.
Nonetheless, stomas have a significant clinical and psychological impact, with complication rates ranging from 33.9% to 45% and reversal rates between 66.5% and 89%.
This study aims to evaluate the feasibility of a no-stoma strategy in a selected "low-risk" population for anastomotic leakage among patients undergoing cytoreductive surgery for primary or recurrent ovarian cancer. Focusing on the goal of achieving a zero stoma rate, the study will provide valuable insights into the utility and outcomes of stoma creation. The results will support more informed and patient-centered clinical decisions in the management of ovarian cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women with ovarian cancer | Experimental | Patients women who underwent colon rectal resection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| colon-rectal resection | Procedure | The patients who underwent colon rectal resection, would be evaluated for stomia or not. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Anastomotic Dehiscence in Low-Risk Patients Undergoing Primary or Secondary Cytoreductive Surgery for Ovarian, Fallopian Tube, or Peritoneal Tumors | The feasibility of a no-stoma policy will be assessed by calculating the rate of anastomotic dehiscence in low-risk patients (who therefore did not receive a diverting stoma) and comparing these results with published data from the literature. | Intraoperative and postoperative follow-up period (90 days postoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Risk Factors for Anastomotic Leak | Identification of preoperative and intraoperative variables associated with anastomotic leak using a multivariable logistic regression model. | preoperative, intraoperative |
| Rate of Occult Anastomotic Leak in Patients With Diverting Ostomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Virginia Vargiu | Contact | +393387106039 | virginia.vargiu@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Virginia Vargiu | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOC Ginecologia Oncologica | Recruiting | Roma | 00168 | Italy |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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Proportion of asymptomatic patients with diverting ostomy presenting with occult anastomotic leak, as assessed by water-soluble rectal contrast enema performed between postoperative days 5 and 10. |
| Postoperative days up to 20. |
| Management Strategies for Anastomotic Leak | Description and distribution of management strategies for anastomotic leak (conservative vs. non-conservative), stratified by low- and high-risk patient groups, and evaluation of the role of ostomy in leak management. | Postoperative period (up to 90 days). |
| Impact of Bowel Surgery on Quality of Life | Change in quality of life and bowel function, as measured by: Gastrointestinal Quality of Life Index (GIQLI) in all patients STOMA questionnaire in patients with diverting ostomy Low Anterior Resection Syndrome (LARS) score Knowles-Eccersley-Scott-Symptom (KESS) questionnaire All questionnaires will be administered preoperatively and at 3 and 6 months post-surgery. | Baseline (pre-surgery), 3 months, and 6 months post-surgery. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |