Chronic Radiation InjuryPhase 3PE-BaconNCT05607927
PE-Bacon for Late Complications of Chronic Radiation-induced Rectal Injury
A Phase 3 study testing Parks surgery and PE-Bacon surgery in people with Chronic Radiation Injury, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Chronic radiation-induced injury (CRII) is a common complication after radiation therapy for pelvic malignancies. Resection surgery could be an optimal surgical approach when CRII is complicated by late complications. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Radiation Injury
- What is being tested?
- Parks surgery and PE-Bacon surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2022to 30 Aug 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Patients aged 18-70 years;
- 2. Patients with Eastern Cooperative Oncology Group (ECOG) physical condition score of 0-2;
- 3. Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system);
- 4. Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy;
- 5. Patients without recurrence or metastasis of primary tumor;
- 6. The late complications of CRII patients, such as deep rectal ulcer (VRS score >=3), rectal sigmoid colon stenosis, obstruction, chronic perforation, rectal necrosis, rectovaginal fistula, intractable anal pain caused by rectal lesions, intractable rectal bleeding which is still difficult to be relieved by stoma operation, and patients who need sigmoid colorectal resection;
- 7. Patients who can tolerate general anesthesia;
- 8. The subjects and their families are able to understand the study plan, willing to participate and sign the informed consent.
Who cannot join
- 1. Patients with acute intestinal obstruction, acute intestinal perforation and intestinal hemorrhage who need emergency operation;
- 2. Patients with severe pelvic adhesion and frozen pelvis;
- 3. Patients with unstable primary tumor or tumor in other parts;
- 4. Patients who need to undergo combined organ resection;
- 5. Patients with a history of sigmoidostomy;
- 6. American society of anesthesiologists (ASA) level IV to V;
Show all 9Show fewer
- 7. Patients with serious mental illness;
- 8. Pregnant or lactating women;
- 9. Patients with serious cardiovascular disease, uncontrollable infection, or other uncontrollable combined diseases.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Laparoscopic Proximally Extended Colorectal Resection With Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Late Complications of Chronic Radiation-induced Rectal Injury: A Prospective, Multicenter, Randomized Controlled Clinical Trail
Chronic radiation-induced injury (CRII) is a common complication after radiation therapy for pelvic malignancies. Resection surgery could be an optimal surgical approach when CRII is complicated by late complications. However, because of high incidence of postoperative complications like anastomotic leakage rate and mortality, doctors try to avoid performing surgical resection. In addition, there is sparse agreement on the types of surgery.
Previous study proved that anastomosis with at least one end of bowel without radiation damage can greatly reduce postoperative anastomotic leakage rate and mortality. And in Bacon surgery, primary anastomosis is not performed, and the anastomotic tension markedly reduced and the blood supply of anastomosis can be judged intuitively to improve the quality of anastomosis in the second stage of intestinal anastomosis to decrease the anastomotic leakage rate. Combining the advantages of proximally extended resection and two-stage anastomosis could minimize potential complications and maximize the therapeutic efficacy in theory, and a small sample prospective clinical study by the investigator have already preliminarily confirmed it. The investigator has also preliminarily proved that Parks surgery is safe and feasible for the treatment of late complications of CRII.
Therefore, this study aims to observe the safety and effectiveness of PE-Bacon surgery with Parks surgery as a control, in order to select more optimal surgical methods and provide a high-level evidence-based medical basis for patients with late complications of CRII.
Read the detailed description
Chronic radiation-induced injury (CRII) is a common complication after radiation therapy for pelvic malignancies. Compared with diversion surgery, resection surgery removes the damaged tissue completely to avoid the risks of recurrence and improve patients' outcome. Hence, resection surgery could be an optimal surgical approach when CRII is complicated by late complications. However, because of high incidence of postoperative complications like anastomotic leakage rate and mortality, doctors try to avoid performing surgical resection. In addition, there is sparse agreement on the types of surgery.
With the advances of surgical techniques and perioperative care, the morbidity and mortality of resection surgery has been decreased significantly. In addition, previous study proved that anastomosis with at least one end of bowel without radiation damage can greatly reduce postoperative anastomotic leakage rate and mortality. And in Bacon surgery, primary anastomosis is not performed, and the anastomotic tension markedly reduced and the blood supply of anastomosis can be judged intuitively to improve the quality of anastomosis in the second stage of intestinal anastomosis to decrease the anastomotic leakage rate. Combining the advantages of proximally extended resection and two-stage anastomosis could minimize potential complications and maximize the therapeutic efficacy in theory, and a small sample prospective clinical study by the investigator have already preliminarily confirmed it. And the investigator has also preliminarily proved that Parks surgery is safe and feasible for the treatment of late complications of CRII.
Therefore, this study aims to observe the safety and effectiveness of PE-Bacon surgery with Parks surgery as a control, in order to select more optimal surgical methods and provide a high-level evidence-based medical basis for patients with late complications of CRII.
- Conditions
- Chronic Radiation Injury
- Being tested
- Parks surgery, PE-Bacon surgery
- Keywords
- PE-Bacon, Parks, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parks surgeryProcedure or surgery
Parks surgery
PE-Bacon surgeryProcedure or surgery
PE-Bacon surgery
| Study group | Role | What they receive |
|---|---|---|
| Parks surgery group | Other | The CRII patients received Parks surgery Receives: Procedure: Parks surgery |
| PE-Bacon surgery group | Experimental | The CRII patients received PE-Bacon surgery Receives: Procedure: PE-Bacon surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ostomy reversal rate within 1 year after surgery
Ostomy reversal rate within 1 year after surgery
Measured: 1 year after surgery
Incidence of anastomotic leakage within 6 months after surgery
Incidence of anastomotic leakage within 6 months after surgery
Measured: 6 months after surgery
Secondary outcomes (15)
Ostomy reversal rate within 2 years after surgery
Ostomy reversal rate within 2 years after surgery
Measured: 2 years after surgery
Ostomy reversal rate within 3 years after surgery
Ostomy reversal rate within 3 years after surgery
Measured: 3 years after surgery
Incidence of anastomotic leakage within 1 year after surgery
Incidence of anastomotic leakage within 1 year after surgery
Measured: 1 year after surgery
Incidence of anastomotic leakage within 2 years after surgery
Incidence of anastomotic leakage within 2 years after surgery
Measured: 2 years after surgery
Incidence of anastomotic leakage within 3 years after surgery
Incidence of anastomotic leakage within 3 years after surgery
Measured: 3 years after surgery
Incidence of anastomotic stricture within 6 months after surgery
Incidence of anastomotic stricture within 6 months after surgery
Measured: 6 months after surgery
Incidence of anastomotic stricture within 1 year after surgery
Incidence of anastomotic stricture within 1 year after surgery
Measured: 1 year after surgery
Incidence of anastomotic stricture within 2 years after surgery
Incidence of anastomotic stricture within 2 years after surgery
Measured: 2 years after surgery
Incidence of anastomotic stricture within 3 years after surgery
Incidence of anastomotic stricture within 3 years after surgery
Measured: 3 years after surgery
Incidence of severe intestinal dysfunction at 1 year after ostomy reversal
Incidence of severe intestinal dysfunction at 1 year after ostomy reversal
Measured: 1 year after ostomy reversal
Incidence of severe intestinal dysfunction at 2 years after ostomy reversal
Incidence of severe intestinal dysfunction at 2 years after ostomy reversal
Measured: 2 years after ostomy reversal
Incidence of severe intestinal dysfunction at 3 years after ostomy reversal
Incidence of severe intestinal dysfunction at 3 years after ostomy reversal
Measured: 3 years after ostomy reversal
Quality of life at 1 year after ostomy reversal
Quality of life at 1 year after ostomy reversal
Measured: 1 year after ostomy reversal
Quality of life at 2 years after ostomy reversal
Quality of life at 2 years after ostomy reversal
Measured: 2 years after ostomy reversal
Quality of life at 3 years after ostomy reversal
Quality of life at 3 years after ostomy reversal
Measured: 3 years after ostomy reversal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start20 Nov 2022 (estimated)
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic Radiation InjuryStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607927
- Sponsor's protocol ID
- PE-Bacon2022
- Acronym
- PE-Bacon
- Status last verified
- Nov 2022
- First submitted
- 26 Sep 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. doi: 10.1002/cncr.21324.
PubMed 16080176Andreyev J. Gastrointestinal symptoms after pelvic radiotherapy: a new understanding to improve management of symptomatic patients. Lancet Oncol. 2007 Nov;8(11):1007-17. doi: 10.1016/S1470-2045(07)70341-8.
PubMed 17976611Perrakis N, Athanassiou E, Vamvakopoulou D, Kyriazi M, Kappos H, Vamvakopoulos NC, Nomikos I. Practical approaches to effective management of intestinal radiation injury: benefit of resectional surgery. World J Gastroenterol. 2011 Sep 21;17(35):4013-6. doi: 10.3748/wjg.v17.i35.4013.
PubMed 22046090McCrone LF, Neary PM, Larkin J, McCormick P, Mehigan B. The surgical management of radiation proctopathy. Int J Colorectal Dis. 2017 Aug;32(8):1099-1108. doi: 10.1007/s00384-017-2803-y. Epub 2017 Apr 20.
PubMed 28429071Zhong Q, Yuan Z, Ma T, Wang H, Qin Q, Chu L, Wang J, Wang L. Restorative resection of radiation rectovaginal fistula can better relieve anorectal symptoms than colostomy only. World J Surg Oncol. 2017 Feb 2;15(1):37. doi: 10.1186/s12957-017-1100-0.
PubMed 28153025Meissner K. Late radiogenic small bowel damage: guidelines for the general surgeon. Dig Surg. 1999;16(3):169-74. doi: 10.1159/000018721.
PubMed 10436361Qin Q, Zhu Y, Wu P, Fan X, Huang Y, Huang B, Wang J, Wang L. Radiation-induced injury on surgical margins: a clue to anastomotic leakage after rectal-cancer resection with neoadjuvant chemoradiotherapy? Gastroenterol Rep (Oxf). 2019 Apr;7(2):98-106. doi: 10.1093/gastro/goy042. Epub 2018 Dec 11.
PubMed 30976422He Y, Zhou Z, Huang X, Guan Q, Qin Q, Zhu M, Wang H, Zhong Q, Chen D, Wang H, Fang L, Ma T. Laparoscopic Proximally Extended Colorectal Resection With Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Late Complications of Chronic Radiation Proctopathy. Front Surg. 2022 Apr 25;9:845148. doi: 10.3389/fsurg.2022.845148. eCollection 2022.
PubMed 35548188Anseline PF, Lavery IC, Fazio VW, Jagelman DG, Weakley FL. Radiation injury of the rectum: evaluation of surgical treatment. Ann Surg. 1981 Dec;194(6):716-24. doi: 10.1097/00000658-198112000-00010.
PubMed 7305485Jao SW, Beart RW Jr, Gunderson LL. Surgical treatment of radiation injuries of the colon and rectum. Am J Surg. 1986 Feb;151(2):272-7. doi: 10.1016/0002-9610(86)90086-3.
PubMed 3946764
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Proximally Extended Colorectal Resection With Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Late Complications of Chronic Radiation-induced Rectal Injury: A Prospective, Multicenter, Randomized Controlled Clinical Trail
- ClinicalTrials.gov ID
- NCT05607927
- Acronym / sponsor ID
- PE-Bacon / PE-Bacon2022
- Conditions
- Chronic Radiation Injury
- Keywords
- PE-Bacon, Parks, complication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (estimated)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 7 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Chronic radiation-induced injury (CRII) is a common complication after radiation therapy for pelvic malignancies. Resection surgery could be an optimal surgical approach when CRII is complicated by late complications. However, because of high incidence of postoperative complications like anastomotic leakage rate and mortality, doctors try to avoid performing surgical resection. In addition, there is sparse agreement on the types of surgery.
Previous study proved that anastomosis with at least one end of bowel without radiation damage can greatly reduce postoperative anastomotic leakage rate and mortality. And in Bacon surgery, primary anastomosis is not performed, and the anastomotic tension markedly reduced and the blood supply of anastomosis can be judged intuitively to improve the quality of anastomosis in the second stage of intestinal anastomosis to decrease the anastomotic leakage rate. Combining the advantages of proximally extended resection and two-stage anastomosis could minimize potential complications and maximize the therapeutic efficacy in theory, and a small sample prospective clinical study by the investigator have already preliminarily confirmed it. The investigator has also preliminarily proved that Parks surgery is safe and feasible for the treatment of late complications of CRII.
Therefore, this study aims to observe the safety and effectiveness of PE-Bacon surgery with Parks surgery as a control, in order to select more optimal surgical methods and provide a high-level evidence-based medical basis for patients with late complications of CRII.
Detailed description
Chronic radiation-induced injury (CRII) is a common complication after radiation therapy for pelvic malignancies. Compared with diversion surgery, resection surgery removes the damaged tissue completely to avoid the risks of recurrence and improve patients' outcome. Hence, resection surgery could be an optimal surgical approach when CRII is complicated by late complications. However, because of high incidence of postoperative complications like anastomotic leakage rate and mortality, doctors try to avoid performing surgical resection. In addition, there is sparse agreement on the types of surgery.
With the advances of surgical techniques and perioperative care, the morbidity and mortality of resection surgery has been decreased significantly. In addition, previous study proved that anastomosis with at least one end of bowel without radiation damage can greatly reduce postoperative anastomotic leakage rate and mortality. And in Bacon surgery, primary anastomosis is not performed, and the anastomotic tension markedly reduced and the blood supply of anastomosis can be judged intuitively to improve the quality of anastomosis in the second stage of intestinal anastomosis to decrease the anastomotic leakage rate. Combining the advantages of proximally extended resection and two-stage anastomosis could minimize potential complications and maximize the therapeutic efficacy in theory, and a small sample prospective clinical study by the investigator have already preliminarily confirmed it. And the investigator has also preliminarily proved that Parks surgery is safe and feasible for the treatment of late complications of CRII.
Therefore, this study aims to observe the safety and effectiveness of PE-Bacon surgery with Parks surgery as a control, in order to select more optimal surgical methods and provide a high-level evidence-based medical basis for patients with late complications of CRII.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parks surgery group | Other | Procedure: Parks surgeryThe CRII patients received Parks surgery |
| PE-Bacon surgery group | Experimental | Procedure: PE-Bacon surgeryThe CRII patients received PE-Bacon surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Patients aged 18-70 years;
- 2. Patients with Eastern Cooperative Oncology Group (ECOG) physical condition score of 0-2;
- 3. Patients with previous pathological diagnosis of pelvic tumors (Gynecology, prostate, urinary system);
- 4. Patients with a history of pelvic radiotherapy, at least 6 months from the end of the last radiotherapy;
- 5. Patients without recurrence or metastasis of primary tumor;
Key exclusion criteria (9 listed)
- 1. Patients with acute intestinal obstruction, acute intestinal perforation and intestinal hemorrhage who need emergency operation;
- 2. Patients with severe pelvic adhesion and frozen pelvis;
- 3. Patients with unstable primary tumor or tumor in other parts;
- 4. Patients who need to undergo combined organ resection;
- 5. Patients with a history of sigmoidostomy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parks surgeryParks surgery | Procedure or surgery | Parks surgery group |
| PE-Bacon surgeryPE-Bacon surgery | Procedure or surgery | PE-Bacon surgery group |
Primary outcome
Ostomy reversal rate within 1 year after surgery
Time frame: 1 year after surgery
Ostomy reversal rate within 1 year after surgery
Incidence of anastomotic leakage within 6 months after surgery
Time frame: 6 months after surgery
Incidence of anastomotic leakage within 6 months after surgery
15 secondary outcomes
Ostomy reversal rate within 2 years after surgery
Time frame: 2 years after surgery
Ostomy reversal rate within 3 years after surgery
Time frame: 3 years after surgery
Incidence of anastomotic leakage within 1 year after surgery
Time frame: 1 year after surgery
Incidence of anastomotic leakage within 2 years after surgery
Time frame: 2 years after surgery
Incidence of anastomotic leakage within 3 years after surgery
Time frame: 3 years after surgery
Incidence of anastomotic stricture within 6 months after surgery
Time frame: 6 months after surgery
Incidence of anastomotic stricture within 1 year after surgery
Time frame: 1 year after surgery
Incidence of anastomotic stricture within 2 years after surgery
Time frame: 2 years after surgery
Incidence of anastomotic stricture within 3 years after surgery
Time frame: 3 years after surgery
Incidence of severe intestinal dysfunction at 1 year after ostomy reversal
Time frame: 1 year after ostomy reversal
Incidence of severe intestinal dysfunction at 2 years after ostomy reversal
Time frame: 2 years after ostomy reversal
Incidence of severe intestinal dysfunction at 3 years after ostomy reversal
Time frame: 3 years after ostomy reversal
Quality of life at 1 year after ostomy reversal
Time frame: 1 year after ostomy reversal
Quality of life at 2 years after ostomy reversal
Time frame: 2 years after ostomy reversal
Quality of life at 3 years after ostomy reversal
Time frame: 3 years after ostomy reversal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Background: PubMed 16080176Delaney G, Jacob S, Featherstone C, Barton M. The role of radiotherapy in cancer treatment: estimating optimal utilization from a review of evidence-based clinical guidelines. Cancer. 2005 Sep 15;104(6):1129-37. doi: 10.1002/cncr.21324.
- Background: PubMed 17976611Andreyev J. Gastrointestinal symptoms after pelvic radiotherapy: a new understanding to improve management of symptomatic patients. Lancet Oncol. 2007 Nov;8(11):1007-17. doi: 10.1016/S1470-2045(07)70341-8.
- Background: PubMed 22046090Perrakis N, Athanassiou E, Vamvakopoulou D, Kyriazi M, Kappos H, Vamvakopoulos NC, Nomikos I. Practical approaches to effective management of intestinal radiation injury: benefit of resectional surgery. World J Gastroenterol. 2011 Sep 21;17(35):4013-6. doi: 10.3748/wjg.v17.i35.4013.
- Background: PubMed 28429071McCrone LF, Neary PM, Larkin J, McCormick P, Mehigan B. The surgical management of radiation proctopathy. Int J Colorectal Dis. 2017 Aug;32(8):1099-1108. doi: 10.1007/s00384-017-2803-y. Epub 2017 Apr 20.
- Background: PubMed 28153025Zhong Q, Yuan Z, Ma T, Wang H, Qin Q, Chu L, Wang J, Wang L. Restorative resection of radiation rectovaginal fistula can better relieve anorectal symptoms than colostomy only. World J Surg Oncol. 2017 Feb 2;15(1):37. doi: 10.1186/s12957-017-1100-0.
- Background: PubMed 10436361Meissner K. Late radiogenic small bowel damage: guidelines for the general surgeon. Dig Surg. 1999;16(3):169-74. doi: 10.1159/000018721.
- Background: PubMed 30976422Qin Q, Zhu Y, Wu P, Fan X, Huang Y, Huang B, Wang J, Wang L. Radiation-induced injury on surgical margins: a clue to anastomotic leakage after rectal-cancer resection with neoadjuvant chemoradiotherapy? Gastroenterol Rep (Oxf). 2019 Apr;7(2):98-106. doi: 10.1093/gastro/goy042. Epub 2018 Dec 11.
- Background: PubMed 35548188He Y, Zhou Z, Huang X, Guan Q, Qin Q, Zhu M, Wang H, Zhong Q, Chen D, Wang H, Fang L, Ma T. Laparoscopic Proximally Extended Colorectal Resection With Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis for Late Complications of Chronic Radiation Proctopathy. Front Surg. 2022 Apr 25;9:845148. doi: 10.3389/fsurg.2022.845148. eCollection 2022.
- Background: PubMed 7305485Anseline PF, Lavery IC, Fazio VW, Jagelman DG, Weakley FL. Radiation injury of the rectum: evaluation of surgical treatment. Ann Surg. 1981 Dec;194(6):716-24. doi: 10.1097/00000658-198112000-00010.
- Background: PubMed 3946764Jao SW, Beart RW Jr, Gunderson LL. Surgical treatment of radiation injuries of the colon and rectum. Am J Surg. 1986 Feb;151(2):272-7. doi: 10.1016/0002-9610(86)90086-3.
Related trials for Chronic Radiation Injury
RecruitingObservational study
Study on Prostate Salvage Using High-dose-rate Brachytherapy
Prostate Cancer, Locally Recurrent Cancer
Enrolling by invitationObservational study
Hypertension and Arrhythmias in CLL Patients Treated With BTK Inhibitors
Chronic Lymphocytic Leukemia, Atrial Fibrillation
RecruitingObservational study
Gene and Molecular Pathways of Ozone Treatment Response in Gynecological Tumor Patients With Chronic Pelvic Pain Secondary to Cancer Treatment
Chronic Pelvic Pain Syndrome (CPPS), Radiation-Induced Disorder
Active, not recruitingObservational study
Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2022 and 2025
Radiation Toxicity, Chemotherapeutic Toxicity
RecruitingObservational study
Patients Referred to the Chronic Pain Unit for Palliative Treatment With Ozone Therapy Between 2026 and 2029.
Chemotherapy-Induced Peripheral Neuropathy, Radiation Toxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Parks surgery and PE-Bacon surgery in people with Chronic Radiation Injury, run by Sixth Affiliated Hospital, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tenghui Ma, PhD (13560232462, matengh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ostomy reversal rate within 1 year after surgery (time frame: 1 year after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05607927, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.