Understanding belly button hernia repair: long-term results and possible complications

The risk factors of seromas and long-term results after umbilical hernia with diastasis recti repair using endoscopic subcutaneous approach (SCOLA)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN28583690

Enrollment

100

Registered

2024-01-24

Start date

2019-01-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diastasis recti, umbilical hernia Musculoskeletal Diseases

Interventions

A prospective cohort study of patients who underwent elective surgery for small and medium size primary umbilical hernia with diastasis recti was performed. The institutional review board’s permissio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who underwent elective surgery for small and medium size primary umbilical hernia with diastasis recti was performed. 2. Age 18-70 years old. 3. With no other diseases.

Exclusion criteria

Exclusion criteria: Patiens who had cardiovascular, pulmonary, oncological diseases.

Design outcomes

Primary

Measure	Time frame
All the patients were examined in the outpatient department 1, 3, 6 and 12 months after surgery: 1. Hernia recurrence and postoperative seromas diagnosis were based on the patient’s physical examination and ultrasound, performed by an experienced radiologist. 2. The patient’s age, gender, hospital stay, hernia size, postoperative general and wound complications, recurrence rate, postoperative pain were measured using patient records 3. Postoperative pain was evaluated using Visual Analogue Scale (VAS). 4. To evaluate quality of life we used the Carolinas Comfort Scale (CCS) questionnaire: 0 - no symptoms; 1 - mild but not bothersome; 2 - mild and bothersome but not daily; 3 - moderate and/or daily symptoms; 4 - severe symptoms; 5 - disabling symptoms. All the patients were asked to fill the questionnaire 1 week and 1 month after surgery. 5. Umbilical hernias size according to the European Hernia Society (EHS) recommendations: small (4 cm). Diastasis recti were classified by the new EHS recommendations. Separation between inter-rectus distance: D1 2-3 cm., D2 3-5 cm., and D3 > 5 cm. Type: T1 - after pregnancy or T2 - with adiposity. Concomitant umbilical or epigastric hernia: H0 - without, H1 - present measured using patient records. 6. The risk factors for seromas formation were analyzed: age, gender, diastasis recti size, hernia defect size, surgical repair technique using patient records	—

Measure

Time frame

All the patients were examined in the outpatient department 1, 3, 6 and 12 months after surgery: 1. Hernia recurrence and postoperative seromas diagnosis were based on the patient’s physical examination and ultrasound, performed by an experienced radiologist. 2. The patient’s age, gender, hospital stay, hernia size, postoperative general and wound complications, recurrence rate, postoperative pain were measured using patient records 3. Postoperative pain was evaluated using Visual Analogue Scale (VAS). 4. To evaluate quality of life we used the Carolinas Comfort Scale (CCS) questionnaire: 0 - no symptoms; 1 - mild but not bothersome; 2 - mild and bothersome but not daily; 3 - moderate and/or daily symptoms; 4 - severe symptoms; 5 - disabling symptoms. All the patients were asked to fill the questionnaire 1 week and 1 month after surgery. 5. Umbilical hernias size according to the European Hernia Society (EHS) recommendations: small (4 cm). Diastasis recti were classified by the new EHS recommendations. Separation between inter-rectus distance: D1 2-3 cm., D2 3-5 cm., and D3 > 5 cm. Type: T1 - after pregnancy or T2 - with adiposity. Concomitant umbilical or epigastric hernia: H0 - without, H1 - present measured using patient records. 6. The risk factors for seromas formation were analyzed: age, gender, diastasis recti size, hernia defect size, surgical repair technique using patient records

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

Lithuania

Contacts

Public ContactLinas Venclauskas

linasvenclauskasg@yahoo.com+370 69881208

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026