Prevention of intraabdominal adhesions after Hartmann-Procedures due to 4Dryfield PH

Prevention of intraabdominal adhesions after Hartmann-Procedures due to 4Dryfield PH - PRADHA-Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00038851

Enrollment

Registered

2026-01-05

Start date

2026-04-01

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Intraabdominal adhesions after Hartmann-Procedure

Interventions

Group 1: Intervention group: Before fascial closure after Hartmann-Procedure, 4Dryfield PH is distributed evenly in the abdominal cave additionally to the standard-of-care lavage. Group 2: Control gr

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Temporary end stoma creation with planned reversal No immunosuppressive medication Written consent

Exclusion criteria

Exclusion criteria: Patients not meeting the specified inclusion criteria Long-term medication with immunosuppressive drugs Frozen abdomen or massive bowel adhesions after 2nd look laparotomies before fascial closure Intraabdominal lavage with another solution than NaCl or Granudacyne Laparoscopic surgery at initial surgery

Design outcomes

Primary

Measure	Time frame
Outcome: Degree of intraabdominal adhesions at the planned stoma reversal When: 6-12 months after the primary Hartmann-Procedure How: The degree of the adhesions is measured with a modified peritoneal adhesion Score (analog to the PAI-Score)	—

Secondary

Measure	Time frame
- Endpoint: Rate of anastomotic leakage after stoma reversal When: Within 3 months after stoma reversal How: Clinical evaluation -Endpoint: Surgical site complications (hematoma/ seroma/ dehiscence/ hernia occurrence) When: until 3 months after stoma reversal How: Clinical evaluation -Endpoint: Postoperative ileus symptoms When: 3 months after initial surgery as well as 3 months after stoma reversal How: using a questionnaire (self-designed) - Endpoint: Postoperative pain intensity When: 3 months and 6 months after initial surgery as well as 3 months after stoma reversal How: using a NRS - Endpoint: Assessment of Quality of Life (QoL) When: 3 months after initial surgery as well as 3 months after stoma reversal How: using the EQ-5D-5L QoL questionnaire - Endpoint: Time from cut to until peritoneum is opened completely during follow-up intervention, complete operation time of the stoma reversal When: At Stoma reversal How: Stopping the time, documentation in the OP-Protocol - Endpoint: Rate of secondary interventions and re-operations When: throughout the study How: Anamnesis at study visits, clinical course - Endpoint: Length of hospital-stay When: after primary operation and stoma reversal How: Documentation in the digital patient record (SAP)	—

Measure

Time frame

- Endpoint: Rate of anastomotic leakage after stoma reversal When: Within 3 months after stoma reversal How: Clinical evaluation -Endpoint: Surgical site complications (hematoma/ seroma/ dehiscence/ hernia occurrence) When: until 3 months after stoma reversal How: Clinical evaluation -Endpoint: Postoperative ileus symptoms When: 3 months after initial surgery as well as 3 months after stoma reversal How: using a questionnaire (self-designed) - Endpoint: Postoperative pain intensity When: 3 months and 6 months after initial surgery as well as 3 months after stoma reversal How: using a NRS - Endpoint: Assessment of Quality of Life (QoL) When: 3 months after initial surgery as well as 3 months after stoma reversal How: using the EQ-5D-5L QoL questionnaire - Endpoint: Time from cut to until peritoneum is opened completely during follow-up intervention, complete operation time of the stoma reversal When: At Stoma reversal How: Stopping the time, documentation in the OP-Protocol - Endpoint: Rate of secondary interventions and re-operations When: throughout the study How: Anamnesis at study visits, clinical course - Endpoint: Length of hospital-stay When: after primary operation and stoma reversal How: Documentation in the digital patient record (SAP)

—

Countries

Germany

Contacts

Public ContactMarkus Götz

Universitätsklinikum Regensburg

markus.goetz@ukr.de+4994194416818

Outcome results

None listed

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